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Clinical Therapeutics

Clinical Pharmacokinetics of Fosfomycin after Continuous Infusion Compared with Intermittent Infusion: a Randomized Crossover Study in Healthy Volunteers

Valentin al Jalali, Peter Matzneller, Beatrix Wulkersdorfer, Scharon Chou, Soma Bahmany, Birgit C. P. Koch, Markus Zeitlinger
Valentin al Jalali
aDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
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Peter Matzneller
aDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
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Beatrix Wulkersdorfer
aDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
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Scharon Chou
aDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
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Soma Bahmany
bHospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands
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Birgit C. P. Koch
bHospital Pharmacy, Erasmus MC, Rotterdam, The Netherlands
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Markus Zeitlinger
aDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria
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DOI: 10.1128/AAC.01375-20
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ABSTRACT

Continuous infusion (CON) of fosfomycin has been proposed as potentially advantageous in certain clinical scenarios. However, no clinical data on the pharmacokinetics (PK) of fosfomycin after CON are available to date. This study aimed to investigate the PK of fosfomycin after CON and compare it with intermittent infusion (INT) of fosfomycin. A randomized two-way crossover study including 8 healthy male volunteers was performed. Each subject received fosfomycin as INT of 8 g over 30 min every 8 h and, separated by a washout period, as CON of 1 g/h preceded by a loading dose of 8 g over 30 min. PK sampling was performed for 18 and 24 h in the CON and INT groups, respectively. Fosfomycin was generally well tolerated. However, 2 out of 8 subjects (25%) developed thrombophlebitis at the infusion site following CON, which was prevented in the following subjects with a simultaneous coinfusion of Ringer’s lactate. The steady-state maximum concentration of drug in serum (Cmax) and area under the concentration-time curve from 0 to 24 h at steady state (AUCSS,0–24) of fosfomycin after INT were 551.5 ± 67.8 mg/liter and 3,678.5 ± 601.9 h · mg/liter, respectively. CON led to an average steady-state concentration of 183.8 ± 35.9 mg/liter, resulting in a calculated AUCSS,0–24 of 4,411.2 ± 862.4 h · mg/liter, which was 1.2-fold higher than that with INT. CON resulted in a 100% T>MIC (time during which the drug concentration exceeds the MIC) for MICs of ≤128 mg/liter, whereas the %T>MIC for INT was only 44% for an MIC of 128 mg/liter. CON of fosfomycin led to improved PK and PK/pharmacodynamic (PD) determinants in plasma of healthy volunteers. The clinical relevance of these findings remains to be investigated in patients.

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Clinical Pharmacokinetics of Fosfomycin after Continuous Infusion Compared with Intermittent Infusion: a Randomized Crossover Study in Healthy Volunteers
Valentin al Jalali, Peter Matzneller, Beatrix Wulkersdorfer, Scharon Chou, Soma Bahmany, Birgit C. P. Koch, Markus Zeitlinger
Antimicrobial Agents and Chemotherapy Dec 2020, 65 (1) e01375-20; DOI: 10.1128/AAC.01375-20

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Clinical Pharmacokinetics of Fosfomycin after Continuous Infusion Compared with Intermittent Infusion: a Randomized Crossover Study in Healthy Volunteers
Valentin al Jalali, Peter Matzneller, Beatrix Wulkersdorfer, Scharon Chou, Soma Bahmany, Birgit C. P. Koch, Markus Zeitlinger
Antimicrobial Agents and Chemotherapy Dec 2020, 65 (1) e01375-20; DOI: 10.1128/AAC.01375-20
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KEYWORDS

PK/PD
clinical trials
continuous infusion
fosfomycin
pharmacokinetics

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